Lesson 3

Question 1

What is the yellow card reporting scheme?

Answer 1

• ‘Early warning signs’ of safety issues
• Collecting and monitoring information on suspected medicine and medicinal device safety concerns and incidents
• Voluntary reporting of ADRs by patients and HCPs
• MHRA reviews products and if necessary takes action to minimise risk and maximise benefit for patients and public

Question 2

Challenges with the yellow card reporting scheme

Answer 2

• Under reporting
• Unreliable
• Complex system

Question 3

What to report in the yellow card reporting scheme?

Answer 3

All serious suspected ADRs especially in children, >65, pregnant women, biological meds and vaccines, associated with delayed drug effects and interactions

Question 4

What is the black triangle scheme?

Answer 4

• New meds and vaccines (will appear on package, SPC, BNF)
  -MHRA maintains list and reviews ~5 years after marketing but no fixed limit (date dependent)
• Confirm the benefit/ risk profile that was established during clinical development
• Ensure that we identify previously unrecognisable side effects as quickly as possible

Question 5

How are meds recalled?

Answer 5

• Class 1: most serve (high chance of causing death) - alert will appear on the website and need removal of supply immediately
• Class 2&3: drugs may cause mistreatment and harm but life threatening
  - Class 2: remove within 48 hrs
  - Class 3: remove within 4 days
• Class 4: continue with caution

Question 6

What is pharmacovigilance?

Answer 6

Capture and evaluate information to take measures to minimise and prevent risk